BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4756805 · Received May 5, 2015

    Report

    Report Number
    1052693-2015-00674
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 14, 2015
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION BLACK CHEMISTRY OBSERVED, NO INVESTIGATION REQUIRED. INVESTIGATION COMPLETED AND METER EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULT. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 95 TO 150 MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NO PERFORMED DUE TO EXPIRED TEST STRIPS. STORAGE OF TEST STRIPS NOT VERIFIED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2014 AND OPEN VIAL DATA NOT VERIFIED. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: "LO" (B)(6) 2015 07:37AM; 99 MG/DL (B)(6) 2014 09:24PM; 161 MG/DL (B)(6) 2014 10:55PM; 160MG/DL (B)(6) 2014 10:56PM; 166 MG/DL (B)(6) 2014 08:45PM.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULT. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 95 TO 150MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT PERFORMED DUE TO EXPIRED TEST STRIPS. STORAGE OF TEST STRIPS NOT VERIFIED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2014 AND OPEN VIAL DATE NOT VERIFIED. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: "LO" (B)(6) 2015 07:37AM. 99MG/DL (B)(6) 2014 09:24PM . 161MG/DL (B)(6) 2014 10:55PM. 160MG/DL (B)(6) 2014 10:56PM. 166MG/DL (B)(6) 2014 08:45PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293437 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1346

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR